Kornimate/medical-research-clean huggingface dataset:
symbiotic yogurt, calcium absorption and bone health in young adult women

Conditions: Osteoporosis

Summary: prebiotics have been linked to increased calcium absorption in animal and human studies (particularly in adolescents and in premenopausal women). similarly, probiotics have been found to benefit calcium homeostasis in pregnant women, and to promote bio-mineralization in animal models. the effect of symbiotic on calcium absorption has been tested in rats, but not in human studies. the primary objective of this study is to investigate the effect of daily consumption of a functional symbiotic yogurt containing inulin and lactobacillus rhamnosus compared to a control yogurt, on calcium absorption in young adult women. a secondary objective is to relate changes in calcium absorption following yogurt consumption, with calcium metabolism, vitamin d status, bone mass, calcium intake and overall composition of habitual diet.

a potential strategy to reduce the risk of osteoporosis later in life is to promote optimal bone mass during early adulthood by including in the diet functional foods that maximize the efficiency of calcium absorption. this approach is specially important in women because of their greater risk for osteoporosis than men. in this study, we hypothesized that the daily consumption of a yogurt containing inulin and lactobacillus rhamnosus (symbiotic yogurt) increases the efficiency of calcium absorption in young adult women when compared to daily consumption of a yogurt of similar composition but without prebiotic or probiotic (control yogurt). subjects in this study will be randomly assigned to consume daily the symbiotic yogurt or the control yogurt during two 3-week periods with a wash-out period of 3-weeks, in a cross-over design. calcium absorption will be measured by stable calcium isotope methodology. bone mass (bmd, bmc) will be measured by dual-y ray absorptiometry. serum intact parathyroid hormone, 25-hydroxyvitamin d and dietary intake will be measured by conventional methods.

Eligibility criteria:
inclusion criteria: * ages 18 to 35 years * generally healthy exclusion criteria: * pregnancy/lactation * bmi \<18,5 kg/m2 * bmi\> 29 kg/m2 * metabolic disorders, bone, liver or kidney disease that may affect calcium metabolism * smoking

Keywords: functional foods dairy foods calcium absorption prebiotics and probiotics young women bone health
collaborative care for depressed elderly in korea

Conditions: Depression; Elderly; Korean; Collaborative Care

Summary: late-life depression is associated with physical limitations, greater functional impairment, increased utilization and cost of health care, and suicide. collaborative care, linking primary and mental health specialty care, has been shown to be effective for the treatment of late-life depression in primary care settings in western countries. the primary aim of this project is to implement a depression care management intervention, and examine its effectiveness on the depressive symptoms of older patients in korean primary care settings. based on chronic disease management theory and previous collaborative care management studies in western countries, we propose to test a depression care management intervention,which includes care manager to support a primary care physician of depression in their old patients. care manager'd role are monitoring the progress of treatment, supporting patient's adherence, educating patients/ family and facilitate communication between providers. also psychiatrists provide consultation and supervision of care managers. using a randomized controlled design, we will examine whether the depression care management is an effective treatment for patients with late life depression in rural korea. the primary outcome would be the improvement of depressive symptoms of patients in primary care setting.


Eligibility criteria:
inclusion criteria: * 60 year or older * diagnosed depression based on dsm-iv criteria exclusion criteria: * impairment of hearing * dementia * other psychiatric disorders
post-marketing surveillance study of docetaxel-based chemotherapy

Conditions: Nonsmall Cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck

Summary: a post-marketing surveillance study to evaluate the effectiveness and safety of docetaxel-based chemotherapy


Eligibility criteria:
inclusion criteria: -histologically or cytologically confirmed unresectable locally advanced nsclc with progressed or recurred after no more than four previous docetaxel-free chemotherapy regimens, or unresectable locally advanced or metastatic scchn or recurred after previous docetaxel-free chemotherapy regimens exclusion criteria: 1. women who are nursing or pregnant during the study period; 2. patients with carcinoid tumors, small-cell carcinoma of the lung; 3. a history of another malignancy within the last five years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the uterine cervix); 4. any other morbidity or situation with contraindications for chemotherapy (e.g. active infection, myocardial infarction in the preceding 6 months); 5. neutrophil counts \< 1,500 cells/mm3; 6. a history of hypersensitivity to docetaxel or cisplatin; 7. symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias; 8. subjects have active hepatitis; 9. subjects are known positive for human immunodeficiency virus (hiv); 10. any condition judged by investigator, participates the study will jeopardize patient's wellbeing
phase 3 study on the efficacy and safety of human plasma derived antithrombin (atenativ) in heparin-resistant patients scheduled to undergo cardiac surgery necessitating cardiopulmonary bypass

Conditions: Acquired Antithrombin Deficiency

Summary: the primary objective of this study is to evaluate the efficacy of two different doses of atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (cpb)


Eligibility criteria:
inclusion criteria: 1. planned cardiac surgery with cpb 2. heparin-resistant patients (pre-cpb hemochron act less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 u/kg ufh) 3. patients between 18 and 85 years of age, inclusive 4. freely given written or electronic informed consent 5. in female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery exclusion criteria: 1. receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery: 1. vitamin k antagonists (within 3 days) 2. direct oral anticoagulants (within 2 days) 3. thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment 4. ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment 5. glycoprotein iib/iiia antagonist (within 24 hours) 2. pre-existing coagulopathy, a history of bleeding problems, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von willebrand disease, platelet disorder) 3. renal insufficiency, defined as serum creatinine level \>2.0 mg/dl 4. known hypersensitivity or allergic reaction to antithrombin or any of the excipients in atenativ i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid 5. history of anaphylactic reaction(s) to blood or blood components 6. refusal to receive transfusion of blood or blood-derived products 7. current participation in another interventional clinical trial or previous participation in the current trial 8. treatment with any imp within 30 days prior to screening visit

Keywords: heparin resistance antithrombin deficiency cardiopulmonary bypass cardiac surgery
effect of tenofovir on genital herpes simplex virus (hsv) shedding

Conditions: Herpes Simplex Type II

Summary: the investigators propose a randomized, double blind, placebo-controlled, cross-over trial to evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex virus (hsv) shedding among herpes simplex virus type-2 (hsv-2) seropositive, human immunodeficiency virus (hiv) seronegative women. the investigators hypothesize that tenofovir will reduce genital hsv shedding compared to placebo.

the investigators propose a randomized, double-blind, placebo-controlled, cross-over study of 55 adult, healthy women who are hsv-2 seropositive and hiv-1 seronegative. women will first participate in a run-in phase with twice daily swabbing. following 4 weeks of swabbing, participants will be randomized 2:2:1 to one of three groups: 1) oral tenofovir and placebo gel, 2) oral placebo and tenofovir gel, or 3) oral placebo and placebo gel. participants will begin treatment and swab the genital region twice daily for 5 more weeks. study drug will be administered daily.

Eligibility criteria:
inclusion criteria: * women age 18-50 * hsv-2 seropositive by the university of washington (uw) western blot * history of recurrent genital herpes, with more than 4 recurrences but less than 10 in the last year or, if currently on suppressive therapy, with more than 4 recurrences but less than 10 in the year prior to starting suppressive therapy * hiv negative * general good health * willing to not use antiviral therapy (other than the study drug) for the duration of the study * willing to obtain a swab from genital secretions twice daily for the duration of the study * willing to use effective birth control * able to provide written informed consent at screening and enrollment exclusion criteria: * hiv positive or at high risk for hiv acquisition (intravenous drug user or hiv+ sex partner) * hepatitis b (hepb) antigen (ag) positive, or at high risk for hepb acquisition and not vaccinated * have a history of adverse reaction to tenofovir and/or adefovir * immunosuppressive medications, except for intranasal or topical (not high potency) steroids. * any kidney disease, or renal insufficiency, defined as serum creatinine \>1.5 mg/dl. participants with a prior history of a single episode of pyelonephritis will be eligible. * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 3 times upper limit of normal * pregnancy, as confirmed by a urine pregnancy test, planning to become pregnant during the course of the trial, or breast-feeding. * serious medical conditions or active infections * any other conditions that in the judgment of the investigator would preclude successful completion of the clinical trial.
enhanced external counterpulsation on delayed onset muscle soreness

Conditions: Muscle Tightness

Summary: this study will evaluate the effects of enhanced external counterpulsation on delayed onset muscle soreness. the primary outcomes will be duration of delayed onset muscle soreness, wbc count, crp count, cpk count, and pain tolerance.


Eligibility criteria:
inclusion criteria: * healthy active duty or dod beneficiaries between 25 and 59 years old exclusion criteria: * not on a physical profile * not taking any otc or prescription pain medications or workout supplements
survey on pre-ect evaluation and ect application

Conditions: Depression; Catatonia; Schizophrenia; Schizoaffective Disorder; Suicidal Intention; Malignant Neuroleptic

Summary: the aim of this study is to identify specifics of pre-ect assessments and ect application in european psychiatric services. we will engage european centres that provide ect for psychiatric patients and for psychiatric indications. it could bring better insights on current standards and possibly give some further improvements in the field of european ect practices.

electroconvulsive therapy (ect) is an extremely important therapeutic method in the treatment of certain psychiatric conditions. its' effect has been demonstrated in many clinical trials, and the indications for the use of ect are clearly defined. thus, the absolute indications for the use of ect are catatonia and malignant neuroleptic syndrome, while the relative indications for ect are therapy-resistant schizophrenia, depression and chronic suicidality. when the lead psychiatrist sets an indication for the use of ect, pre-ect evaluation is conducted. although the pre-evaluation aims to assess the psychophysical condition of the patient and to determine the potential risks and possible side effects of such therapy, no clear algorithm of procedures is specified. there is no data on clear guidelines for the necessary processing prior to the application of ect, both at national levels and globally. the assessment recommendations, however, are very broad, and most of them are focused on the ethical issues of applying ect. the standardized pre-ect evaluation would provide physicians and patients a systematic and evidence-based risk assessment and presumption of adverse reaction profiles.

Eligibility criteria:
inclusion criteria: * departments that provide pre-ect assessment * departments that provide ect application * departments that provide both pre-ect assessment and ect application exclusion criteria: * departments that used to provide either pre-ect assessment or ect application * departments that refer patients for ect but don't provide pre-ect assessment

Keywords: electroconvulsive therapy pre-ect evaluation
feasibility study of the jewelpump version 3

Conditions: Type 1 Diabetes

Summary: the study will be conducted, in cross-over with a time interval of at least 2 days between 2 treatment periods. patients will be randomized into 2 groups according to the order of the randomization, patients will bear the jewelpump for 5 days, followed by a period of 5 days of treatment with their usual pumps.

the jewelpump (debiotech) will be compared to the conventional pumps. patients will treated with the jewelpump during 5 days, and with their usual pump during 5 other days. the study will be conduct with 15 patients at the following investigation centers : corbeil hospital, chu of strasbourg, and chru of marseille.

Eligibility criteria:
inclusion criteria: * patients type 1 diabetics treated by external insulin pump; * patients with hba1c \< 8.5% * patients who signed consent exclusion criteria: * patients type 2 diabetics * patients who have all serious diseases that could interfere with the study

Keywords: glycemic control jewelpump accuracy
pdn post market, multicenter, prospective, global clinical study

Conditions: Diabetic Neuropathy, Painful

Summary: the purpose of this post-market study is to evaluate the real-world experience of nevro's spinal cord stimulation (scs) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (pdn). this is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for pdn patients. outcomes will be assessed via standardized assessments.


Eligibility criteria:
inclusion criteria: to participate in the study, patients must meet all the following inclusion criteria: 1. have been clinically diagnosed with diabetes, according to the local country diabetes association guidelines, as well as painful diabetic neuropathy (pdn) of the lower limbs refractory to conventional medical management. 2. average pain intensity (over the last 7 days) of ≥5 out of 10 cm on the visual analog scale (vas) in the lower limbs at enrollment/baseline. 3. the clinical decision has been made to provide treatment using the nevro spinal cord stimulation that includes 10 khz therapy prior to enrollment in the study. 4. be willing and capable of giving written informed consent. 5. be willing and able to comply with study-related requirements and procedures and attend all scheduled visits. exclusion criteria: to participate in the study, patients must not meet any of the following exclusion criteria: 1. have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes, or have large (≥3 cm) and/or gangrenous ulcers of the lower limbs 2. have a medical condition or diagnosis that is inconsistent with nevro's scs system guidelines in the physician's manual for the relevant country, or as per standard clinical practice. 3. have a medical condition or pain in other areas, not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound the evaluation of study endpoints, as determined by the investigator (such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, peripheral vascular disease, or small vessel disease).

Keywords: spinal cord stimulation (scs)
comprehensive study of post-surgical pain after pectus or spine surgery

Conditions: Pain, Postoperative; Excavatum, Pectus; Scoliosis Idiopathic

Summary: this will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic effects, side effects to perioperative analgesics, chronic postoperative pain, and gene expression in patients following pectus excavatum repair.

this study will be a clinical prospective study. it is observational for all aims except with regard to the meditation intervention, which will be limited to 100 pectus and 100 spine participants (randomized to 50/50 in each arm). we will recruit 600 qualifying participants over the study period to acquire the necessary data to derive a predictive model matching phenotype to genotype. this study will not interfere with the standard anesthetic or perioperative care except for blood sampling from an indwelling line, and the use of additional integrative health procedures (focused-attention meditation guidance, as well as routine massage and breathing techniques) for the randomized meditation group. research staff will administer psychosocial and somatosensory assessments, as well as record relevant data from participant's medical records. integrative health will assist in teaching focused-attention meditation to the randomized meditation participants in the preoperative phase. actigraphy devices will be provided to all participants, and musetm to those in the randomized meditation group. the pain team, in accordance with the pectus pain management protocol, will direct perioperative pain management.

Eligibility criteria:
inclusion criteria: * children aged 8 years of age through adulthood * diagnosis of pectus excavatum or adolescent idiopathic scoliosis * scheduled for endoscopic pectus excavatum repair or spine fusion exclusion criteria: * history of or active renal or liver disease * major surgery requiring opioids in the last 5 years * severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month) * cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, hypertension with ongoing treatment, kawasaki disease, or cardiomyopathies. participants with asymptomatic valvular lesions or defects may be included * history of seizures currently treated on medication (participants off medication and seizure free for greater than one year may be included) * taking no more than two concomitant medications known to induce or inhibit cyp2d6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine * needing postoperative ventilation or intraoperative cardiac bypass standby * bmi \>35 * pregnant or breastfeeding females * non-english speaking * definite developmental delay

Keywords: meditation pectus excavatum scoliosis
the related factors of bariatric surgery on bone mineral density

Conditions: Bone Mineral; Bariatric Surgery

Summary: obesity and related metabolic diseases have become a chronic disease that is a threat to human health. bariatric surgery can effectively and long-term reduce excess body weight and relieve related metabolic diseases, including type 2 diabetes. laparoscopic gastric bypass surgery and laparoscopic sleeve gastrectomy are commonly used in bariatric surgery. laparoscopic sleeve gastrectomy due to simple operation, good weight loss, and metabolic disease control effect, which is more widely used. however, there are several studies that show an increased chance of gastroesophageal reflux disease after laparoscopic sleeve gastrectomy. long-term gastroesophageal reflux may lead to barrett's esophagus or esophageal cancer. nowadays, the cause of gastroesophageal reflux disease after sleeve gastrectomy is not clear and precautionary measures are not precise. in this study, prospective randomized controlled trials were conducted to explore the possible causes of bone mineral after bariatric surgery and to explore ways to prevent bone mineral after bariatric surgery.


Eligibility criteria:
inclusion criteria: -for the choice of surgical approach, numerous studies have shown that bmi ≧ 45, the general choice of gastric bypass surgery, bmi \<45, you can choose sleeve gastrectomy. the remission rate for t2dm, sleeve gastrectomy has a good result for young patients with shorter duration. in our country, the bmi less than 45 is majorities. exclusion criteria: -bmi\<27.
study of periodontal tissues in fixed prostheses on natural teeth

Conditions: Prosthetic Tissue Defect; Dental Prosthesis Complication; Dental Prosthesis Failure; Tissue Injury

Summary: when the tooth is severely compromised, it needs a prosthetic crown. the tooth is prepared to allow the housing of the prosthetic crown without difficulty. this study aims to compare two different types of preparations to see with which of the two the gingival tissue reacts best.


Eligibility criteria:
inclusion criteria: 1. need for restoration by single-tooth prosthetic crown, due to destructive caries, coronal fracture, endodontically treated tooth, severe abrasion, aesthetic problems, remake of old incongruous prosthetic crown, other complications. 2. if there are incongruous conservative restorations (composite fillings or other materials) in the elements adjacent to the tooth to be treated, these must be restored before the prosthetic therapy and must not be modified during the protocol. 3. absence of active periodontal disease 4. over the age of 18; 5. periodontal probing less than 4 mm in the tooth to be treated 6. absence of bleeding on probing 7. full-mouth plaque score (fmps) and full-mouth bleeding scores (fmbs) \< 20% at the start of the study 8. patients according to protocol participation and informed consent signature. exclusion criteria: 1. contraindication to dental treatment 2. active periodontal disease 3. systemic diseases that may affect periodontitis 4. pregnant women 5. patients in orthodontic therapy 6. inability to return to the controls or to follow oral hygiene maintenance.